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It was not possible for patients or investigators to guess the next allocated medication in order to avoid selection or allocation biases.
The GP is informed about the randomization results and sends a prescription of the allocated medication to the patient's pharmacy.
Patients take their allocated medication on demand, and can change their medication intake when their pain level alters.
A unique, confidential randomization number was assigned to each patient and IVRS/IWRS allocated medication accordingly, as assigned, throughout the respective treatment periods.
Another researcher handed each bottle of study medication to the patient and instructed them to take their allocated medication once a day before their evening meal.
Research staff will also ensure patients receive proper allocated medication dosages, monitor for adherence and AEs and initiate rescue medication where appropriate.
Similar(53)
Costs are calculated from the allocated treatment, medication, hospitalization, etc.
Patients will receive the same allocated study medication throughout their course of ECT.
All analyses were carried out by intention to treat, including all patients who received the first dose of allocated study medication.
Unblinding of treatment only takes place if the identity of the allocated study medication was necessary for patient safety and care.
A secondary per protocol analysis was also performed that examined only cases where patients took their allocated trial medication and did not violate trial protocol (table 3).
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CEO of Professional Science Editing for Scientists @ prosciediting.com